§1.1113. What are the eligibility requirements for a recognized accreditation body?
21 C.F.R. § 1.1113
A recognized accreditation body or an accreditation body seeking recognition must meet all of the following requirements:
Demonstrates compliance with ISO/IEC 17011— 2017(E) (incorporated by reference, see § 1.1101).
Demonstrates that it is a full member of the International Laboratory Accreditation Cooperative (ILAC).
Demonstrates that it is a signatory to the ILAC Mutual Recognition Arrangement (MRA) that has demonstrated competence to ISO/IEC 17011:2017(E) with a scope of “Testing: ISO/IEC 17025.”
Will comply with all additional requirements for recognized accreditation bodies under this subpart while recognized.
Notes, amendments, and revision history
Source
Source: 86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.
Authority
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.
Source
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.